What plasma is and how it is donated

Plasma is the pale-yellow liquid component of blood that normally holds the blood cells in suspension. It makes up about 55% of the total volume of an individual's blood. Plasma donation is the process of collecting a donor's blood, separating the plasma portion of the blood from the blood cells, and then returning the blood cells to the donor. This process takes between 1 to 2 hours and is known as plasmapheresis.

Products made from plasma

Plasma is the starting material used for the manufacturing of life-saving, commercial drugs known as plasma products.

Commonly used plasma products include:

albumin, which is used to treat fluid loss in burn or trauma patients;

immune globulins, which are used to treat or prevent infections or immune disorders; and

clotting factors, which are used for the treatment of haemophilia as well as other bleeding disorders.

Plasma collection in Canada

In Canada, both Canadian Blood Services and Héma-Québec:

collect plasma for manufacturing into plasma products;

purchase US plasma products; and

distribute plasma products to Canadian hospitals.

Under strict regulations of the Food and Drugs Act, private companies can also collect plasma for the production of essential plasma products.

Canada's plasma needs

There is not enough plasma collected in Canada to meet the demand for plasma products. Most of the plasma products distributed by Canadian Blood Services and Héma-Québec are purchased from US manufacturers and made from US paid-donor plasma, e.g. about 80% of our immune globulin comes from the US. Most developed countries also depend on products made from paid-donor plasma. The current reality is that plasma from paid donors is needed to meet Canadian demand for plasma products.

Safety of plasma

In Canada, all establishments collecting plasma for plasma products, whether from volunteer or paid donors, are strictly regulated and must comply with the Food and Drugs Act and Blood Regulations. Plasma products sold in Canada are manufactured in accordance with strict safety standards, regardless of where the plasma comes from, and whether or not donors were paid.

Paying plasma donors

Provinces and territories decide whether and how plasma is collected in their jurisdictions. Some provinces prohibit private clinics and companies from paying plasma donors. Neither Canadian Blood Services nor Héma-Québec pay their donors for either blood or plasma.

There are some private clinics in Canada that pay donors for plasma. For example, in Winnipeg, some plasma donors have been paid for more than 30 years. Most of the plasma products distributed in Canada are purchased from the US where payment for plasma donation is very common. In both Canada and the US, plasma from paid and unpaid donors is equally safe because of strict protocols at every stage of collection, testing and production.

Krever Commission recommendations

Lessons of the tainted blood crisis of the 1980s must never be forgotten. Many Canadians who used plasma products during that period were infected with HIV and/or hepatitis. In 1997, the Government of Canada released the final report of the Commission of Inquiry on the Blood System in Canada (Krever Commission). Action has been taken since then to help prevent a tragedy like that from happening again. The recommendations of the Krever report are the foundation of Health Canada’s approach to blood and plasma regulation.

The Krever Commission report recommended that blood donors should not be paid, and all blood transfused in Canadian hospitals continues to come from Canadian unpaid blood donors. Regarding plasma products, since well before the Krever report Canada has been heavily dependent on products made from paid-donor plasma. This is still true in Canada and most other countries. Part of Justice Krever’s concern was product safety, and the Panel report confirms that much has changed since the Krever report—there is no difference in safety between products made from volunteer and paid donors. Technology has advanced significantly over the years and made these products safer. There has not been a single case of transmission of hepatitis B, hepatitis C or HIV caused by plasma products since the introduction of modern manufacturing practices over 20 years ago, and this includes plasma products sourced from the US where most plasma donors are paid.

Under Canada’s Food and Drugs Act, all plasma collection applications received are reviewed to ensure the safety of plasma collected, regardless of whether donors will be paid. As a responsible regulator, Health Canada continues to incorporate advances in science and modern techniques, such as those that are now used in plasma product manufacturing, into its regulatory processes.

Regulating plasma donation in Canada

The federal law that governs the collection of plasma used for making plasma products is the Food and Drugs Act and the Blood Regulations.

Licensing the establishment

Any establishment that collects plasma for use in making plasma products must be licensed and authorized by Health Canada. The licence application must show that its donor screening and testing processes meet the strict requirements under the law. For example, before donors are accepted into a plasma donation program they must be determined to be eligible to donate. In addition to a comprehensive questionnaire and interview, donors must be physically examined for health and disease risk factors. At the time of every donation, donors are re-interviewed and their blood is tested for infectious diseases, including HIV and hepatitis B and hepatitis C.

Inspecting the establishment

Before a licence is granted, Health Canada inspects the establishment to verify that it meets the safety standards set out under the Food and Drugs Act. The establishment is then inspected annually to assess that it is following the law. Health Canada will take compliance and enforcement actions for establishments that are not meeting these requirements, which could result in the loss of their licence. Furthermore, all plasma products are subjected to an additional regulatory review before they are authorized for distribution in Canada. This regulatory review includes careful examination of the plasma collection and product manufacturing processes.

Prospective donors

Health Canada's stringent regulatory oversight serves to complement the global standards that plasma collectors adhere to as set by the Plasma Protein Therapeutics Association (PPTA). As part of PPTA's International Quality Plasma Program certification criteria, plasma collection facilities must verify that prospective donors can provide proof of a fixed residential address within a set proximity to the collection centre, and which is checked against a list of transient, temporary residences to exclude donors who may be part of some higher risk populations. Potential donors must also give two donations with negative disease test results before they are considered qualified and, for donors who do not return for their second donation, the plasma from their first donation is destroyed. More information on the international standards for plasma donation is available on the PPTA website.

In 2017, Health Canada established an Expert Panel to provide an evidence-based assessment of the sustainability of Canada's immune globulin supply in an increasingly competitive global market, and of the potential impact on the blood supply if private plasma collection expanded significantly in Canada. Background on the Panel and its final report are available here: https://www.canada.ca/en/health-canada/programs/expert-panel-immune-globulin-product-supply-related-impacts-canada.html.

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